US Congress moves to protect FDA user fees

Bipartisan legislation introduced in the US House of Representatives seeks to exempt Food and Drug Administration user fees from sequestration starting from fiscal 2014.

User fees are 100%-industry financed and, under sequestration, the FDA is set to lose fees worth $85 million in fiscal 2013 alone, say the legislators, launching their FDA Safety Over Sequestration (FDA SOS) Act.

"Whether one agrees or disagrees with sequestration, I don't believe private dollars should be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely therapies," said Republican Anna Eshoo, one of the bill's authors.

Democrat Doris Matsui, another of the bill's authors, added: “it is essential to ensure that the FDA is able to fully achieve its performance targets in the clinical testing and approval "of the innovative therapies that millions of people are hoping and waiting for. These patients, many of whom are battling deadly diseases, should not be deprived of potentially lifesaving therapies due to delays caused by political gamesmanship in Washington."

Sequestration was triggered by the Budget Control Act of 2011 as part of efforts to resolve the US debt-ceiling crisis. It introduced automatic federal spending cuts totalling $85.3 billion that took effect on March 1 2013.

The FDA SOS Act is supported by many industry groups, including the California Healthcare Institute (CHI), which points out that the 2012 FDA Safety and Innovation Act (FDASIA), which renewed the agency's authority to collect user fees, included an undertaking from industry to pay higher fees to fund needed improvements in the FDA review processes.

While sequestration has cut around 5% of FDA's appropriated budget, its locking up of around $83million in user fees this year is disrupting the agency's product review processes, threatening to delay patient access to innovative new technologies and further aggravating an already-significant downturn in life sciences venture capital investment, says CHI.

The Pharmaceutical Research and Manufacturers of America (PhRMA) also welcomes FDA SOS, and points out that prescription drug user fees cannot, by law, be used for any purpose other than to support FDA's human drug review programme.

"Their sequestration does not decrease the nation's deficit, but only serves to exacerbate the severe budgetary constraints of a historically underfunded agency. This is detrimental to patients, regulatory science and public health," says PhRMA's vice president of scientific and regulatory affairs, Sascha Haverfield.